The Food and Drug Administration (FDA) acts as public health protector by ensuring that all products within its jurisdiction are safe and effective. Authority to do this comes from the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act). Title 21 of the Code of Federal Regulations contains the regulations enforced by FDA. Where felonies are associated with violations of the FD&C Act and its implementing regulations, FDA has a number of statutes at its disposal. Title 18 (Crimes and Criminal Procedures) of the United States Code (USC) provides many of these statutes. This online training course will describe several felony criminal statutes available for use by FDA that are not part of Title 21 of the USC. These are statutes that have been used in the past and are most likely to be used for felony violations associated with Title 21 criminal prosecutions. After completing this healthcare compliance course, you should understand what constitutes criminal felony behavior, the means by which FDA proves criminal intent, and specific elements of proof for the statutes covered in this eLearning course.